Kornimate/medical-research-clean huggingface dataset:
a trial to compare automated lyumjev delivery with carbohydrate counting, qualitative meal-size estimation, and meal detection in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Type 1 Diabetes

Summary: the goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (lyumjev) and an automated insulin delivery system. the meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. the investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes. participants will test each meal strategy in random order, and each meal strategy will be 21 days long. for the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called lyumjev.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes for at least 12 months. the diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria. * insulin pump use for at least 3 months. * individuals of childbearing potential must agree to use a highly effective method of birth control. * willing to switch to lyumjev insulin for the duration of the study. exclusion criteria: * use of oral antihyperglycemic agents within 2 weeks of admission (sglt2i, metformin...); 1 month for glp1-ra. * use of glucocorticoids (except low, stable doses and inhaled steroids). * use of hydroxyurea. * planned or ongoing pregnancy. * breastfeeding. * diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission. * clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator. * recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery. * known hypersensitivity to the study drug or its excipients. * other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.
withdrawal of steroids, cyclosporine a dose reduction and switch to mycophenolatmofetile after heart transplantation

Conditions: Heart Transplantation

Summary: the purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the cyclosporine a dose. the concomitant administration of mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.

the decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects. calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.

Eligibility criteria:
inclusion criteria: * current immunosuppressive regimen: cyclosporine a and corticosteroids for at least six month * heart transplantation above 3 years dated back * serum creatinine \< 3,5 mg/dl (310 µmol/l) and bun \< 150 mg/dl * cyclosporine a blood level between 50 and 250 ng/ml during the last 12 month exclusion criteria: * carcinoma within the last 3 years * acute rejection episodes during the last 6 month * infection requiring therapeutic intervention * hepatitis b, hepatitis c or hiv infection * wbc \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl * florid gastrointestinal ulcer * haemodialysis within the last 4 weeks before study entry * pregnancy / lactation * administration of other immunosuppressive agents than prescribed * mycophenolatmofetile incompatibility

Keywords: cyclosporine glucocorticoids renal insufficiency, chronic long-term care
phase iv trial,the efficacy and safety study of fuganlin oral liquid in children with acute upper respiratory infection

Conditions: Acute Upper Respiratory Infection

Summary: phase iv trial,single-arm, multi-centre clinical trial to assess the efficacy and safety of fuganlin oral liquid in children with acute upper respiratory infection

low-dose group of fuganlin oral liquid:dosage from 5 to 10 ml; high-dose group of fuganlin oral liquid:dosage from 10 to 20 ml; treatment for 1 week.patients who were recovered within 1 week can withdrawal at any time. research purpose: 1. evaluate the safety and efficacy of fuganlin oral liquid when expanding the designated indications(qi deficiency wind-heat syndrome to wind-heat syndrome) . 2. explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,while treating with fuganlin oral liquid in children with acute respiratory infection. 3. observe the antiviral and immunomodulatory effects of fuganlin oral liquid. 4. provide data to support the clinical medicine guidelines and labels amendment of fuganlin oral liquid.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as acute upper respiratory infection. 2. patients with acute upper respiratory infection diagnosed as tradition chinese medicine syndrome qi deficiency wind-heat. 3. patients aged 1 to 12 years old. 4. parents or guardians agreed to participate this study and signed the informed consent. exclusion criteria: 1. patients whose total numbers of white blood cells around above1.3uln. 2. patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway. 3. patients allergic to the test drug. 4. serious cardiovascular, liver,kidney and other primary systemic diseases. 5. patients should not be included in group according to investigator's evaluation.

Keywords: acute upper respiratory infection
case fatalities in hospitalised covid-19 patients in the uk

Conditions: Covid19

Summary: this study will investigate how the case fatality in hospitalised patients with covid-19 has changed throughout the pandemic. it will also explore possible mechanisms that could be driving these changes. this analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.


Eligibility criteria:
inclusion criteria: * all patients admitted with a proven or high likelihood of covid-19

Keywords: covid-19 isaric hospitalisations mortality case fatality united kingdom
comparison of excision versus punch incision in the treatment of epidermal cysts

Conditions: Epidermal Cyst

Summary: the purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. surgical excision removes the entire cyst but requires a larger hole in the skin. a punch incision makes a smaller hole through which the cyst can be removed. the trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.

the purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. surgical excision removes the entire cyst but requires a larger hole in the skin. a punch incision makes a smaller hole through which the cyst can be removed. the trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects. patients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. the skin will be stitched shut in both cases. a short survey about how the cyst affects the patient will be given before the cyst is removed. when the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. the study doctor will be blinded as to which procedure each subject underwent. forty subjects will be recruited at the atlanta veteran's administration medical center

Eligibility criteria:
inclusion criteria: * adult 18 years or older * epidermal cyst 1-3 cm in diameter on the trunk exclusion criteria: * infected cyst requiring systemic antibiotics * pregnant females * unable to return to clinic for suture removal * previous excision of target cyst

Keywords: epidermal cyst epidermoid cyst sebaceous cyst pilar cyst
single arm trial to evaluate the safety and effectiveness of the route 92 medical reperfusion system

Conditions: Acute Ischemic Stroke

Summary: the objective of the study is to evaluate the safety and effectiveness of the route 92 medical monopoint reperfusion system with the hi point 88 and hipoint 70 reperfusion catheters when used to aspirate emboli in acute ischemic stroke patients.

the objective of the study is to evaluate the safety and effectiveness of the route 92 medical monopoint reperfusion system with the hi point 88 and hipoint 70 reperfusion catheters when used to aspirate emboli in acute ischemic stroke patients. the study design is an interventional, prospective, single-arm, open label clinical trial.

Eligibility criteria:
inclusion criteria: 1. the consent process has been completed with the subject, legally authorized representative, or two physician best interest and consent is documented 2. age \>18 years 3. clinical signs consistent with an acute ischemic stroke 4. baseline national institutes of health stroke scale (nihss) score \>= 6 5. pre-stroke modified rankin score (mrs) \<= 2 6. acute occlusion of the m1 segment of the middle cerebral artery (mca), internal carotid artery (ica), vertebral or basilar arteries confirmed via computed tomography angiography (cta) and/or magnetic resonance angiography (mra) 7. the investigator estimates that at least one delivery of the route 92 medical reperfusion system can be completed within 24 hours of time last known well 8. in the opinion of the investigator, reperfusion of the ischemic territory will result in clinical benefit 9. angiographic confirmation of an occlusion of the m1 segment\* of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified thrombolysis in cerebral infarction (mtici) scale score of 0-1 exclusion criteria: 1. known pregnancy or breast feeding 2. known comorbidity that may complicate treatment or prevent improvement or follow-up 3. known life expectancy \< 12 months 4. known history of severe allergy to contrast medium 5. subject known to have suffered a stroke in the past 90 days 6. subject participating in another study involving an investigational device or drug. 7. known connective tissue disorder affecting the arteries (e.g. marfan syndrome, fibromuscular dysplasia, ehlers-danlos syndrome) 8. any known pre-existing hemorrhagic or coagulation deficiency 9. computed tomography (ct) or magnetic resonance imaging (mri) evidence of recent/ fresh hemorrhage 10. baseline ct or mri showing intracranial tumor (except small meningioma) 11. angiographic evidence of dissection in the extracranial or intracranial arteries 12. angiographic evidence of carotid dissection 13. angiographic evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation). note: tandem occlusions may be included at the discretion of the operating physician.
serum ca9 level as biological marker of the treatment response in metastatic renal cell cancer

Conditions: Metastatic Kidney Cancer; Metastatic Renal Cell Carcinoma

Summary: one third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery. medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or il-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (vegf), anti-tyrosine kinase inhibitors and m-tor). these treatments sometimes associated (or il2 + inf or inf antivegf) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. the treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. a serum marker of tumor development would be particularly welcome. ca9 is an oncogene also know as ca ix, carbonic anhydrase 9 or mn/ca9. the gene encoding an oncoprotein called indifferently membrane antigen mn, mn/ca9 isoenzyme, carbonic anhydrase ix ca9, g250/mn/ca9 or protein g250. it was demonstrated that the level of expression of ca9 in tumor tissue can be used as a predictive marker of response to immunotherapy. in previous studies, the investigators tried to use ca9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. more recently, the investigators have developed the elisa and quantitative reat time polymerase chain reaction (rt-pcr) to study the ca9 protein and ca9 mrna in the serum of patients with non-metastatic kidney cancer. the investigators have thus shown that ca9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.

we propose a pilot study of ca9 serum in patients with adenocarcinoma metastatic cell treated by conventional immunotherapy and / or targeted therapy. this pilot study aims to test the ca9 serum marker of response to medical treatment

Eligibility criteria:
inclusion criteria: * conventional renal cell cancer with a pathological diagnosis * metastatic disease * consent form signed * social security regimen affiliated exclusion criteria: * other cancer treated

Keywords: biological markers ca9 protein metastatic conventional renal cell cancer kidney cancer
monoclonal antibody therapy in treating children with metastatic neuroblastoma in second remission

Conditions: Neuroblastoma

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of monoclonal antibody in treating children with metastatic neuroblastoma in second remission.

objectives: i. evaluate the efficacy of ganglioside gd2-specific monoclonal antibody 3f8 as adjuvant therapy in patients with stage iv neuroblastoma in second remission. outline: biological response modifier therapy. antiganglioside gd2-specific monoclonal antibody 3f8, moab 3f8. projected accrual: a maximum of 20 patients will be entered.

Eligibility criteria:
disease characteristics: histologically confirmed, stage iv neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: physical examination second-look surgery bone scan bone marrow aspiration and biopsy chest x-ray ct mibg urinary catecholamines if marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites) patient characteristics: age: under 18 performance status: not specified life expectancy: greater than 12 weeks hematopoietic: grade 4 cytopenias allowed grade 3 marrow hypoplasia allowed hepatic: not specified renal: no renal dysfunction worse than grade 3 cardiovascular: no cardiac dysfunction worse than grade 2 pulmonary: no pulmonary dysfunction worse than grade 2 other: no neurologic dysfunction worse than grade 2 hearing deficit allowed prior concurrent therapy: prior murine antibody therapy allowed provided circulating hama titer is less than 1,000 u/ml serum by elisa

Keywords: disseminated neuroblastoma recurrent neuroblastoma
a study of new medicine (gsk 372475) for the treatment of depression

Conditions: Depressive Disorder

Summary: to evaluate the efficacy, safety, and tolerability of gsk372475 compared with placebo in the treatment of outpatient subjects with major depressive disorder (mdd)

a ten-week, multicenter, randomized, double-blind, placebo and active-controlled, parallel-group, flexible-dose study evaluating the efficacy, safety, and tolerability of gsk372475 (1.5 mg/day to 2.0 mg/day) or extended release venlafaxine xr (150 mg/day to 225 mg/day) compared to placebo in adult subjects diagnosed with major depressive disorder

Eligibility criteria:
inclusion criteria: * major depressive episode (mde) associated with major depressive disorder (dsm-iv-tr criteria) * duration of current episode is at least 12 weeks duration and less than 2 years * symptoms of decreased energy, pleasure, and interest * female subjects who agree to use acceptable methods of birth control throughout the study exclusion criteria: * current diagnosis of panic disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial * symptoms of mde better accounted for by another diagnosis * diagnosis of bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia. * started psychotherapy within 3 months prior to the screening * received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening * received psychoactive drugs within 4 weeks of randomization * positive urine drug screen or positive blood alcohol * suicidal risk or has had any previous suicide attempt, a family history of suicide attempt * positive pregnancy test * history of seizure disorder, myocardial infarction (\< 1yr), or unstable medical condition * failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants

Keywords: flexible-dose gsk372475 mdd venlafaxine xr major depressive disorder
acquisition of breast mammography images

Conditions: Breast Cancer

Summary: this is a case collection study of breast images using standard and new mammography technology.

this image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. this study will create a library of image data that will be used for future projects.

Eligibility criteria:
inclusion criteria: for screening subjects * be at least 40 years of age, are * asymptomatic, * scheduled for a routine screening mammogram for recall subjects * be at least 18 years of age, * received a birads 0 within the last 60 days * are recalled for additional imaging for diagnostic subjects * be at least 18 years of age, * scheduled for a biopsy due to an assessment of breast imaging and reporting data (bi-rads®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days. * understand requirements and willing to participate in study exclusion criteria: * presence of a breast implant. * women with only a single breast; for example, post mastectomy patients. * is pregnant or believes she may be pregnant. * a woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding. * a woman who has significant existing breast trauma within the last one year. * have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations. * a woman who has had a mammogram performed for the purpose of therapy portal planning within the last year. * cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution. * is an inmate (see us code of federal regulations 45cfr46.306).

Keywords: imaging mammography
radiation plus concurrent nimotuzumab in elderly patients with locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: radiation plus concurrent nimotuzumab in elderly patients with locoregionally advanced nasopharyngeal carcinoma

elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).

Eligibility criteria:
inclusion criteria: * previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma exclusion criteria: * a history of another invasive cancer, prior rt to the head and neck area, prior cytotoxic chemotherapy or anti-egfr therapy or the presence of any serious medical conditions, supposed to live less than 6 months.
plyometric exercise training in athletes with chronic low back pain

Conditions: Low Back Pain, Mechanical

Summary: the aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study.

visual analog scale (vas) for pain assessment and oswestry disability index for disability level will be used. sit and reach test, vertical jump, flamingo balance test and shuttle running test (20 min.) will be used to measure the physical functioning of the participants. manual muscle testing will also be used to measure the participants' lower and upper muscles. the participants were divided into two groups. the interventional program will be finished after 6 weeks (3 days a week). the program includes; physical therapy session (hot packed, vacuum interferential current therapy, therapeutic ultrasound, exercises) and plyometric exercises.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-25 * being a licensed athlete (male of famele) * low back pain is chronic and lasts at least 3 months exclusion criteria: * having had back pain or any surgery that caused it in the last year. * having cardiovaskular disease * doping and using banned substances.

Keywords: chronic low pain plyometric exercise physiotherapy athlete
immune response to the human papillomavirus vaccine in young women with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease; Uterine Cervical Dysplasia

Summary: the gardasil vaccine, a vaccine targeted towards the human papillomavirus (hpv), has been shown to prevent the transmission of several strains of hpv in young women. women with inflammatory bowel disease (ibd) may not respond as well to this vaccine, either due to having ibd or due to immunosuppressants used to control ibd. this study will test how well women with ibd respond to the gardasil vaccine.

although guidelines exist for immunization of patients with inflammatory bowel disease, few studies exist demonstrating vaccine efficacy in this population. in patients with inflammatory bowel disease, lower than normal humoral responses have been shown with the tetanus toxoid booster, oral cholera, and influenza vaccinations. it is currently uncertain whether women with inflammatory bowel disease (ibd) have an increased risk of cervical dysplasia and cancer. gardasil, a vaccine against human papilloma viruses (hpv) 6, 11, 16, and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages 9-26 years. however, its immune response in immunocompromised or immunosuppressed patients is unknown. young women with inflammatory bowel disease who have not received the hpv vaccine will receive the vaccine. the vaccine is given in 3 doses over 6 months. response to the vaccine will be measured 6 months after completing the vaccine series.

Eligibility criteria:
inclusion criteria: 1. women 9-26 years of age 2. have inflammatory bowel disease (ie. crohns disease or ulcerative colitis) exclusion criteria: 1. pregnancy 2. taking corticosteroids 3. allergy to yeast aluminum component of the hpv vaccine 4. positive for all hpv types in the gardasil vaccine-6, 11, 16, 18

Keywords: inflammatory bowel disease crohn disease ulcerative colitis papillomavirus vaccines